Data / Medical devices / China / Henan Tuoren Medical Device Co., Ltd.
Henan Tuoren Medical Device Co., Ltd.: FDA-registered device maker in Changyuan Henan, China, 1 510(k) clearance
Henan Tuoren Medical Device Co., Ltd. is registered with the FDA (registration 3006984712) in Changyuan Henan, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 10, 2016. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006984712
- Address
- Weiyuan Industrial Zone, Menggang, Changyuan, 453400 Henan, CHINA Middle of Weft 7 Road, Nanpu District, Changyuan, 453400 Henan, CHINA, Changyuan Henan, China, 453400
- Owner or operator
- Henan Tuoren Medical Device Co., Ltd. (10025262)
- Roles
- Manufacturer
- First device listed
- March 28, 2008
- Registered through
- 2027
- Brand names listed
- Anesthetic Mask(Bending edge model: 0#,1#,2#,3#,4#,5#; Detachable model: 3#,4#,5#; Inflatalbe model:0#,1#,2#,3#,4#,5#), Blockbuster Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#), Breathing Circuit, Heat and Moisture Exchanger (Specifications: Adult/Child/infant/Tracheotomy), Medical Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#), Oropharyngeal airway (Model: 4#, 5#, 6#, 7#, 8#, 9#, 10#, 11#, 12#, 3cm~12cm), Tuoren Double-lumen Endotracheal Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2016 | K152251 | Endobronchial Tube | CBI | Substantially Equivalent | Henan Tuoren Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Mask, Gas, Anesthetic
Updated June 10, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.